The Director of Regulatory Global Labeling (REG-GL) is a strategic role leading the development of labeling for products worldwide. Responsibilities may include developing the strategy for labeling content for Target Product Profiles, Company Core Data Sheets, Prescribing Information, Patient Labeling, and Instructions for use. The incumbent will be responsible for regulatory compliant, competitive, and up-to-date labeling. The Director/Senior Director of REG-GL provides regulatory labeling leadership to the labeling team and cross functional teams where Reg labeling membership is required. Manage the strategic regulatory labeling health authority interactions labeling negotiations worldwide. The Director/Senior Director is responsible for ensuring the execution of global regulatory labeling are aligned with the global regulatory strategy and corporate goals. Oversees and mentors labeling professionals to achieve regulatory objectives.
This position will be responsible for:
Providing regulatory strategic guidance and oversight of global labeling activities for BioMarin commercial products and development products in the metabolism and endocrinology, cell and gene therapy other therapeutic areas as assigned.
An active member on regulatory, development, and commercial teams supporting the strategy and identify requirements to ensure labeling claims support the regulatory plans and are in-line with corporate goals.
Lead the labeling teams, which will include participants around the globe.
Ensuring commercial product labeling is compliant with the worldwide regulations and BioMarin procedures.
Create and lead the development of labeling processes at BioMarin.
Present strategic global labeling issues to Regulatory Management and Executive Management on an ad-hoc/issue-driven basis for assigned projects/products.
Provide strategic input on interpretation and implementation of key regional labeling regulations, guidelines, and best labeling practices, and align with global strategic labeling plan.
Responsible for the development of labeling negotiations strategic plan for the assigned therapeutic area(s) and conduct health-authority reviews and label negotiations (in writing, phone or in person as needed). Lead US and EU labeling negotiations for the assigned products. Guide/ support REG International for all labeling related HA negotiations and participate in labeling negotiation meetings or teleconferences with HAs, as needed.
Oversight and leadership of the International labeling and compliance with CCDS, local requirements, business strategies, and overall quality.
Lead or direct the creation of high quality documents supporting changes to the CCDS or local labeling with internal and/or external experts including responses to labeling-related Health Authority queries. Review of summary documents such as clinical overviews to ensure the labeling message is consistent with the overall representation of a marketing application.
Present and defend proposed labeling changes in global product information documents, including labeling documents in key markets to Senior Management as required for review and approval.
Interactions with RA worldwide: Interact with Regulatory International and regional Partners to ensure timely implementation of global labeling changes and new market submissions and approvals.
Guide launch teams on launch strategy for new commercial products. Provide Supply Chain and QA guidance on labeling implementation requirements.
Ensure all labeling documents are of the highest quality and represent the safe and effective use of the products
A minimum of 12 years required of industry experience and extensive experience (at least 4-6 years) in global labeling, alternatively extensive experience in related areas of the Pharmaceutical Industry or Health Authorities.
Experienced leader with management and direct reports.
Experience negotiating with internal and external stakeholders on complex regulatory issues of importance to BioMarin.
Seasoned regulatory professional with experience in submissions for products in development and commercial products.
Thorough understanding of regulatory labeling requirements and strategic labeling planning.
Outstanding interpersonal and communication (written and verbal) skills.
Attention to detail and highly organized.
Prior experience leading cross functional teams.
History of solving regulatory labeling related problems while exhibiting superior judgment and a balanced, realistic understanding of issues.
Fluency in English as business language, additional languages advantageous.
Expertise in global labeling and managing project teams including international teams (not in the same time-zone).
Biologics and rare disease experience is desirable.
US and/or EU labeling expertise required and International and Core Labeling experience preferred.
Minimum requirements Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.
This position will have supervisory role with direct report(s).